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A Phase I Study of iPS Cell Generation From Patients With COPD

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01860898
First Posted: May 23, 2013
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic
  Purpose
As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.

Condition Intervention
Thoracic Diseases Respiratory Tract Diseases Cancer of Lung Cancer of the Lung Lung Cancer Lung Diseases, Obstructive COPD Pulmonary Emphysema Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Other: Skin Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I Study of iPS Cell Generation From Patients With COPD

Resource links provided by NLM:


Further study details as provided by Dennis Wigle, Mayo Clinic:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 1 year ]
    As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, we will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells. Markers of induced pluripotent phenotype will be utilized to assess successful reprogramming.


Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Skin Biopsy Other: Skin Biopsy
Biopsy samples will be taken as a 2mm x 2cm excision of a wedge of skin at the edge of the incision during your surgery at the Mayo Clinic Rochester. Such excisions are frequently done as part of routine skin closure for optimal skin cosmesis following the surgical procedure.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing Thoracic Surgery at the Mayo Clinic Rochester
  • Presence of a Thoracic Disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860898


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dennis A Wigle, MD, PhD Mayo Clinic
  More Information

Responsible Party: Dennis Wigle, M.D., P.h.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01860898     History of Changes
Other Study ID Numbers: 09-005334
First Submitted: May 21, 2013
First Posted: May 23, 2013
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by Dennis Wigle, Mayo Clinic:
lung
cancer
thoracic
chest
pulmonary

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Lung Diseases
Emphysema
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Diseases
Lung Diseases, Obstructive
Pulmonary Emphysema
Carcinoma, Small Cell
Lung Neoplasms
Thoracic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pulmonary Disease, Chronic Obstructive